ESI of the cervical or lumbar spine with or without added anesthetic agents may be medically necessary when all of the following criteria are met:

The individual has radicular pain; AND

The pain is interfering with functional activities; AND

The pain has not responded to 6 weeks of appropriate conservative therapy*; AND

There is no evident systemic infection or local infection at the injection site, bleeding tendency, or unstable medical condition; AND

ESI can be repeated up to 4 times per cervical or lumbar spinal region per 12 months with at least one week between injections, so long as the prior injection in that spinal region produced at least partial symptomatic relief.

Repeat ESI performed in the absence of documented improvement in pain or function upon reassessment;

Repeat ESI performed more frequently than once weekly;

More than 4 ESI injections at the same spinal region in one year.

Coding

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

CPT

62310

Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic [when specified as epidural steroid injection]

62311

Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal) [when specified as epidural steroid injection]

Acute pain from injury, surgery or illness is usually self-limited and disappears when the underlying cause has been treated or has healed. Chronic pain can persist despite the fact that the cause (e.g., injury, disease) has resolved. The intensity will vary from mild to severe disabling pain that may significantly reduce quality of life.

One type of injection used for the treatment of cervical and lumbar radicular pain is ESI using anesthetic agents or steroids alone or in combination. An epidural steroid injection targets the epidural space that is localized to the area of affected nerve roots. According to the American Academy of Orthopaedic Surgeons (AAOS) "most spinal injections are performed as one part of a more comprehensive treatment program. Simultaneous treatment nearly always includes an exercise program to improve or maintain spinal mobility (stretching exercises) and stability (strengthening exercises) (2009)."The ASA (1997) has stated that the goals of pain management are to:

optimize pain control, recognizing that a pain-free state may not be achievable;

Pain management presents a major challenge to healthcare providers because of its complex natural history and unclear etiology. Clinical decision making for diagnosing and treating chronic pain is difficult due to the subjective nature of pain. The results of clinical studies of epidural steroid injections vary with respect to the degree and duration of pain relief and it is difficult to standardize treatment models.

In a 2008 update of the Cochrane Database Systematic Review, Staal and associates stated that the effectiveness of injection therapy for low-back pain is still debatable. Heterogeneity of target tissue, pharmacological agent and dosage generally found in randomized controlled trials (RCTs) points to the need for clinically valid comparisons in a literature synthesis. However, it cannot be ruled out that specific subgroups of individuals may respond to a specific type of injection therapy.

Chou and colleagues (2009) evaluated clinical data for the American Pain Society Clinical Practice Guideline: Nonsurgical Interventional Therapies for Low Back Pain. They found that evidence from randomized, placebo controlled trials showing benefits of most interventional injection therapies for back pain is limited. For radiculopathy, there is fair evidence of benefits associated with epidural steroid injections however; the decision to use epidural steroid injection should take into account the short-term nature of symptom relief and inconsistent results of epidural steroid trials. More well-designed randomized trials are needed to guide appropriate use of injection therapy for back pain.

The North American Spine Society (NASS) in its Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Degenerative Lumbar Spinal Stenosis 2007 states:

Non fluoroscopically-guided interlaminar epidural steroid injections can result in short term (two to three weeks) symptom relief in patients with neurogenic claudication or radiculopathy. There is, however, conflicting evidence concerning long-term efficacy.

NASS's recommendations (2007) were:

A large double-masked, randomized, controlled clinical trial with at least one-year follow-up in patients with unilateral leg pain from lumbar spinal stenosis treated by fluoroscopically-guided contrast-enhanced transforaminal epidural steroid injections in which the control group receives saline placebo injections.

A large double-masked, randomized, controlled clinical trial with at least two-year follow-up in patients with neurogenic claudication from lumbar spinal stenosis treated by fluoroscopically-guided interlaminar or caudal epidural steroid injections in which the control group receives saline placebo injections.

A preliminary report by Manchikanti et al. (2010) evaluated the safety and effectiveness of thoracic epidural injections in 40 participants who underwent treatment for relief of chronic mid and upper back pain secondary to radiculitis or disc herniation with local anesthetic alone or local anesthetic with steroids. At 12 months, 80% of the patients in the anesthetic alone group reported at least 50% pain reduction while 85% of patients receiving local anesthetic plus steroid reported at least 50% pain reduction (p value not reported). This pilot study was small and lacked a sham control group to measure treatment effect. Currently there are ongoing trials evaluating the use of ESIs for the thoracic region.

Currently, there is limited evidence to support the use of epidural steroids in the treatment of spinal stenosis. Guidelines from the American Pain Society (2009) concluded that there is "insufficient evidence to adequately evaluate the benefits and harms of epidural steroid injections for spinal stenosis."

Manchikanti and colleagues (2012) reported results from a double-blind sham controlled study of 100 participants who underwent lumbar epidural injections of local anesthetic with steroids (Group I; n=50) or without steroids (Group II; n=50) for chronic function-limiting low back pain and lower extremity pain secondary to spinal stenosis The authors reported " the significant pain relief and functional status improvement were seen in 50% in group I and 57% in group II at the end of 2 years in a subset (" the successful group") of participants. However, overall significant pain relief and functional status improvement (greater than or equal to 50%) was demonstrated in 38% of group I and 44% in group II at the end of 2 years." Limitations of the study included its small size and a modest treatment effect in a minority of participants. Further study is needed.

The lumbar epidural steroid injections for spinal stenosis (LESS) study (Friedly et al. 2012 study protocol) is an ongoing randomized, double-blind trial evaluating the effectiveness of ESIs in improving pain and function among adults with lumbar spinal stenosis. Estimated trial completion is 2015. Currently, there is insufficient evidence supporting the use of ESI for the treatment of spinal stenosis.

van Wijck et al. (2006) reported results of the The PINE study of epidural steroids and local anaesthetics to prevent postherpetic neuralgia. In a randomized controlled trial, 598 participants with acute herpes zoster either received standard therapy (oral antivirals and analgesics) or standard therapy and one additional epidural steroid injection. After one, three and six month evaluations, they found that an epidural injection had a modest effect in reducing zoster associated pain after only one month and that this treatment is not effective for prevention of long term postherpetic neuralgia.

Definitions

Non-radicular back pain: Pain which does not radiate along a dermatome (sensory distribution of a single root). Appropriate imaging does not reveal signs of spinal nerve root compression and there is no evidence of spinal nerve root compression seen on clinical exam.

Radicular back pain: Pain which radiates along a dermatome (sensory distribution of a single root) into an upper or lower extremity. Evidence of spinal nerve root compression may be seen on clinical exam and supported by appropriate imaging (generally Magnetic Resonance Imaging [MRI]) studies.

Radiculopathy:Radiculopathy is characterized by pain which radiates from the spine to extend outward to cause symptoms away from the source of the spinal nerve root irritation.

Straight Leg Raise Test:In the supine position and the leg is elevated, with the knee held in extension by the clinician, up to 70 degrees; a positive test reproduces radicular pain along the path of a nerve root in the 30- to 70-degree range of elevation.

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